Z-2291-2025Class I

Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A...

Name: Z-2291-2025 Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A...
Creator: Thoratec LLC
Published: 2025-06-23
License: https://open.fda.gov/license/

Abbott Medical / initiated 2025-06-23 / Open, Classified / root cause: supplier

FDA source

Thoratec LLC began a recall of Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular... on 2025-06-23. FDA classified it as Class I and gives the reason as "Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as supplier.

Recall record

Recall number: Z-2291-2025
Classification: Class I
Status: Open, Classified
Initiated: 2025-06-23
Posted: 2025-08-13
Recalling firm: Abbott Medical
Product: Brand Name: HeartMate Product Name: Mobile Power Unit Model/Catalog Number: 107754 Software Version: N/A Product Description: The HeartMate 3" Left Ventricular Assist System (LVAS) is a set of equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology. The LVAS features a Left Ventricular Assist Device (LVAD), a blood pump intended for long-term implantation in such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve the desired therapeutic benefit. The HeartMate II Left Ventricular Assist System is an axial-flow, rotary ventricular assist system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular Assist Device is attached to the apex of the left ventricle; the other end of the device connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the weakened left ventricle and propels it to the aorta. A small external computer, the System Controller, monitors system operation. A driveline, which passes through the patient s abdomen, connects the implanted pump to the System Controller. The system is powered by a Power Module or Mobile Power Unit (MPU) that is connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries. The LVAS may be used in any of two configurations. First, line power may be utilized through the Power Module or the Mobile Power Unit (MPU) to run the LVAD indefinitely, convenient for sedentary or sleeping periods. Second, portable Battery power may be utilized for limited periods, convenient for active periods. The MPU AC power cord is distributed either as part of the complete MPU device package or as a standalone accessory. Component: Yes, the MPU is a component of the HeartMate 3 and HeartMate II Left Ventricular Assist Systems.
Product code: DSQ Ventricular (Assist) Bypass
Reason for recall: Due to misaligned V-Lock feature on the Mobile Power Unit power cords, which prevents the locking mechanism from properly engaging with the Mobile Power Unit and may cause unintended disconnect.
Root cause tag: supplier
FDA root cause: Vendor change control
Action: Customer advisory letters dated June 23, 2025, will be hand delivered and by email to all impacted consignees. The customer advisory letters will be posted on the Abbott Product Advisory website for further visibility. As stated in the customer letter, affected AC Power Cords from US and OUS consignees and patient units that are experiencing connection issues will be returned and replaced. Instruction to Customers: Refer to "User Action Requested" section in attached customer letter for instructions to consignees. (Attachment D1, D2, and D3)
Quantity in commerce: 604
Distribution: Worldwide - US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NM, NY, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV and the countries of Canada, Japan.
Product codes and lots: Lot Code: US Model No 107754; UDI-DI 05415067038234 Serial Numbers, see Attachment F.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2291-2025
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2290-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-13
Z-2291-2025	Class I	Ongoing	Voluntary: Firm initiated	2025-08-20	2025-08-13

Product code DSQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)